Generic Name
Semaglutide
Brand Names
Wegovy, Ozempic, Rybelsus
FDA approval date: September 20, 2019
Classification: GLP-1 Receptor Agonist
Form: Injection, Tablet
What is Wegovy (Semaglutide)?
WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in: adults with an initial body mass index of [see Dosage and Administration.
Approved To Treat
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Brand Information
WEGOVY (semaglutide)
WARNING: RISK OF THYROID C-CELL TUMORS
- In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined
- WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
1INDICATIONS AND USAGE
WEGOVY is indicated in combination with a reduced calorie diet and increased physical activity:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight.
- to reduce excess body weight and maintain weight reduction long term in:
- Adults and pediatric patients aged 12 years and older with obesity
- Adults with overweight in the presence of at least one weight-related comorbid condition.
- for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.
The indication for MASH is approved under accelerated approval based on improvement of MASH and fibrosis
Limitations of Use
WEGOVY contains semaglutide. Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.
2DOSAGE FORMS AND STRENGTHS
Injection: clear, colorless solution available in 5 prefilled, disposable, single-dose pens:
- 0.25 mg/0.5 mL
- 0.5 mg/0.5 mL
- 1 mg/0.5 mL
- 1.7 mg/0.75 mL
- 2.4 mg/0.75 mL
3CONTRAINDICATIONS
WEGOVY is contraindicated in the following conditions:
- A personal or family history of MTC or in patients with MEN 2
- A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with WEGOVY
4ADVERSE REACTIONS
The following serious adverse reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-Cell Tumors
- Acute Pancreatitis
- Acute Gallbladder Disease
- Hypoglycemia
- Acute Kidney Injury due to Volume Depletion
- Severe Gastrointestinal Adverse Reactions
- Hypersensitivity Reactions
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes
- Heart Rate Increase
- Suicidal Behavior and Ideation
- Pulmonary Aspiration During General Anesthesia or Deep Sedation
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Clinical Trials in Adults with Obesity or Overweight for Weight Reduction
WEGOVY 2.4 mg Subcutaneous Weekly Dosage
WEGOVY was evaluated for safety in 3 randomized, double-blind, placebo-controlled trials that included 2,116 adult patients with obesity or overweight treated with 2.4 mg WEGOVY for up to 68 weeks and a 7-week off-drug follow-up period
In these clinical trials, 6.8% of patients treated with 2.4 mg WEGOVY and 3.2% of patients treated with placebo permanently discontinued treatment as a result of adverse reactions. The most common adverse reactions leading to discontinuation were nausea (1.8% versus 0.2%), vomiting (1.2% versus 0%), and diarrhea (0.7% versus 0.1%) for WEGOVY and placebo, respectively.
Adverse reactions reported in clinical trials in adults and greater than or equal to 2% of WEGOVY-treated patients and more frequently than in placebo-treated patients are shown in
Table 2. Adverse Reactions (≥2% and Greater Than Placebo) in WEGOVY-treated Adults with Obesity or Overweight for Weight Reduction
a Includes abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain, abdominal tenderness, abdominal discomfort and epigastric discomfort
b Includes fatigue and asthenia
c Defined as blood glucose <54 mg/dL with or without symptoms of hypoglycemia or severe hypoglycemia (requiring the assistance of another person) in patients with type 2 diabetes not on concomitant insulin (Study 3, WEGOVY N=403, Placebo N=402). See text below for further information regarding hypoglycemia in patients with and without type 2 diabetes. T2DM = type 2 diabetes mellitus
d Includes chronic gastritis, gastritis, gastritis erosive, and reflux gastritis
e Includes paresthesia, hyperesthesia, burning sensation, allodynia, dysesthesia, skin burning sensation, pain of skin, and sensitive skin
d Includes chronic gastritis, gastritis, gastritis erosive, and reflux gastritis
e Includes paresthesia, hyperesthesia, burning sensation, allodynia, dysesthesia, skin burning sensation, pain of skin, and sensitive skin
In a CV outcomes trial, 8,803 patients were exposed to WEGOVY for a median of 37.3 months and 8,801 patients were exposed to placebo for a median of 38.6 months
Adverse Reactions in a Clinical Trial of Pediatric Patients Aged 12 Years and Older with Obesity for Weight Reduction
WEGOVY was evaluated in a 68-week, double-blind, randomized, parallel group, placebo-controlled, multi-center trial in 201 pediatric patients aged 12 years and older with obesity
Table 3 shows adverse reactions reported in greater than or equal to 3% of WEGOVY-treated pediatric patients and more frequently than in the placebo group from a study in pediatric patients aged 12 years and older.
Table 3. Adverse Reactions (≥3% and Greater than Placebo) in WEGOVY-Treated Pediatric Patients Aged 12 Years and Older with Obesity for Weight Reduction
Adverse Reactions in Clinical Trials in Adults with MASH
The safety of WEGOVY was evaluated in a randomized, double-blind, placebo-controlled trial (Study 8) that included 1,195 adult patients with MASH, including 800 patients who were exposed to WEGOVY for a median of 95.3 weeks and 395 patients who were exposed to placebo for a median of 83.1 weeks
The most commonly reported adverse reactions were consistent with the other approved WEGOVY indications (see
Other Adverse Reactions in Adults and/or Pediatric Patients
Acute Pancreatitis
In WEGOVY clinical trials in adults for weight reduction, acute pancreatitis was confirmed by adjudication in 4 WEGOVY-treated patients (0.2 cases per 100 patient years) and 1 in placebo-treated patients (less than 0.1 cases per 100 patient years). One additional case of acute pancreatitis was confirmed in a patient treated with WEGOVY in another clinical trial.
Acute Gallbladder Disease
In WEGOVY clinical trials in adults for weight reduction, cholelithiasis was reported by 1.6% of WEGOVY-treated patients and 0.7% of placebo-treated patients. Cholecystitis was reported by 0.6% of WEGOVY-treated adult patients and 0.2% of placebo-treated patients. In a clinical trial in pediatric patients aged 12 years and older for weight reduction
Hypoglycemia
Patients with Type 2 Diabetes
In a trial of adult patients with type 2 diabetes and BMI greater than or equal to 27 kg/m
Patients without Type 2 Diabetes
Episodes of hypoglycemia have been reported with GLP-1 receptor agonists in adult patients without type 2 diabetes mellitus. In WEGOVY clinical trials in adult patients without type 2 diabetes mellitus for weight reduction, there was no systematic capturing or reporting of hypoglycemia.
In a CV outcomes trial in adult patients without type 2 diabetes, 3 episodes of serious hypoglycemia were reported in WEGOVY-treated patients versus 1 episode in placebo. Patients with a history of bariatric surgery (a risk factor for hypoglycemia) had more events of serious hypoglycemia while taking WEGOVY (2.3%, 2/87) than placebo (0%, 0/97).
Acute Kidney Injury
Acute kidney injury occurred in clinical trials for weight reduction in 7 adult patients (0.4 cases per 100 patient years) receiving WEGOVY versus 4 patients (0.2 cases per 100 patient years of exposure) receiving placebo. Some of these adverse reactions occurred in association with gastrointestinal adverse reactions or dehydration. In addition, 2 patients treated with WEGOVY had acute kidney injury with dehydration in other clinical trials. The risk of renal adverse reactions with WEGOVY was increased in adult patients with a history of renal impairment (trials included 65 patients with a history of moderate or severe renal impairment at baseline), and occurred more frequently during dose titration.
Retinal Disorders in Patients with Type 2 Diabetes
In a trial of adult patients with type 2 diabetes and BMI greater than or equal to 27 kg/m
Increase in Heart Rate
Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed with routine clinical monitoring in WEGOVY-treated adult patients compared to placebo in clinical trials for weight reduction. In weight reduction trials in which adult patients were randomized prior to dose-escalation, more patients treated with WEGOVY, compared with placebo, had maximum changes from baseline at any visit of 10 to 19 bpm (41% versus 34%, respectively) and 20 bpm or more (26% versus 16%, respectively). In a clinical trial for weight reduction in pediatric patients aged 12 years and older with normal baseline heart rate, more patients treated with WEGOVY compared to placebo had maximum changes in heart rate of 20 bpm or more (54% versus 39%).
Hypotension and Syncope
Adverse reactions related to hypotension (hypotension, orthostatic hypotension, and decreased blood pressure) were reported in 1.3% of WEGOVY-treated adult patients versus 0.4% of placebo-treated patients and syncope was reported in 0.8% of WEGOVY-treated patients versus 0.2% of placebo-treated patients in clinical trials for weight reduction. Some reactions were related to gastrointestinal adverse reactions and volume loss associated with WEGOVY. Hypotension and orthostatic hypotension were more frequently seen in patients on concomitant antihypertensive therapy. In a clinical trial in pediatric patients aged 12 years and older for weight reduction, hypotension was reported in 2.3% of WEGOVY-treated patients versus 0% in placebo-treated patients.
Appendicitis
Appendicitis (including perforated appendicitis) occurred in 10 (0.5%) WEGOVY-treated adult patients and 2 (0.2%) patients receiving placebo in clinical trials for weight reduction.
Gastrointestinal Adverse Reactions
In clinical trials in adults for weight reduction, 73% of WEGOVY-treated patients and 47% of patients receiving placebo reported gastrointestinal adverse reactions, including severe reactions that were reported more frequently among patients receiving WEGOVY (4.1%) than placebo (0.9%). The most frequently reported reactions were nausea (44% vs. 16%), vomiting (25% vs. 6%), and diarrhea (30% vs. 16%). Other reactions that occurred at a higher incidence among WEGOVY-treated adult patients included dyspepsia, abdominal pain, abdominal distension, eructation, flatulence, gastroesophageal reflux disease, gastritis, hemorrhoids, and hiccups. These reactions were most frequently reported during dosage escalation.
In the pediatric clinical trial for weight reduction, 62% of WEGOVY-treated patients and 42% of placebo-treated patients reported gastrointestinal adverse reactions. The most frequently reported reactions were nausea (42% vs. 18%), vomiting (36% vs. 10%), and diarrhea (22% vs. 19%). Other gastrointestinal-related reactions that occurred at a higher incidence than placebo among WEGOVY-treated pediatric patients included abdominal pain, constipation, eructation, gastroesophageal reflux disease, dyspepsia, and flatulence.
Permanent discontinuation of treatment as a result of a gastrointestinal adverse reaction occurred in 4.3% of WEGOVY-treated adult patients versus 0.7% of placebo-treated patients. In a pediatric clinical trial for weight reduction, 2.3% of patients treated with WEGOVY versus 1.5% of patients who received placebo discontinued treatment as a result of gastrointestinal adverse reactions.
Injection Site Reactions
In clinical trials in adults for weight reduction, 1.4% of WEGOVY-treated patients and 1% of patients receiving placebo experienced injection site reactions (including injection site pruritus, erythema, inflammation, induration, and irritation).
Hypersensitivity Reactions
Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with WEGOVY.
In a pediatric clinical trial for weight reduction, rash was reported in 3% of WEGOVY-treated patients and 0% of placebo-treated patients, and urticaria was reported in 3% of WEGOVY-treated patients and 0% of placebo-treated patients
In adult clinical trials for weight reduction, allergic reactions occurred in 16% (8/50) of WEGOVY-treated patients with anti-semaglutide antibodies and in 7% (114/1,659) of WEGOVY-treated patients who did not develop anti-semaglutide antibodies
Fractures
In the CV outcomes trial in adults, more fractures of the hip and pelvis were reported on WEGOVY than on placebo in female patients: 1% (24/2,448) vs. 0.2% (5/2,424), and in patients ages 75 years and older: 2.4% (17/703) vs. 0.6% (4/663), respectively.
In a clinical trial in adults with MASH, fractures occurred in 4.4% of WEGOVY-treated patients (2.6 cases per 100 patient years) compared to 3.3% of placebo-treated patients (2 cases per 100 patient years). Fractures were reported in both males and females with a median age of 61 years (range, 44-75).
Urolithiasis
In a CV outcomes trial, 1.2% of WEGOVY-treated patients and 0.8% of patients receiving placebo reported urolithiasis, including serious reactions that were reported more frequently among patients receiving WEGOVY (0.6%) than placebo (0.4%).
Dysgeusia
In clinical trials in adults for weight reduction, 1.7% of WEGOVY-treated patients and 0.5% of placebo-treated patients reported dysgeusia.
Laboratory Abnormalities
Amylase and Lipase
Adult and pediatric patients treated with WEGOVY had a mean increase from baseline in amylase of 15 to 16% and lipase of 39% in clinical trials for weight reduction. These changes were not observed in the placebo group.
In a clinical trial in adults with MASH, increases in lipase greater than 3 times the upper limit of normal (ULN) occurred in 4.7% (35/750) of WEGOVY-treated patients compared with 1.3% (5/374) of placebo-treated patients. The clinical significance of elevations in lipase or amylase with WEGOVY is unknown in the absence of other signs and symptoms of pancreatitis.
Liver Tests
In a pediatric clinical trial for weight reduction, increases in alanine aminotransferase (ALT) greater than or equal to 5 times the ULN were observed in 4 (3%) WEGOVY-treated patients compared with 0% of placebo-treated patients. In some patients, increases in ALT and AST were associated with other confounding factors (such as gallstones). In the CV outcomes trial in adults, increases in total bilirubin greater than or equal to 3 times the ULN were observed in 0.3% (30/8,585) of WEGOVY-treated patients versus 0.2% (14/8,579) of placebo-treated patients.
4.2Postmarketing Experience
The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of WEGOVY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction.
Hypersensitivity: anaphylaxis, angioedema, rash, urticaria
Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing
elective surgeries or procedures requiring general anesthesia or deep sedation
Renal and Urinary Disorders: acute kidney injury
5OVERDOSAGE
Overdoses have been reported with other GLP-1 receptor agonists. Effects have included severe nausea, severe vomiting, and severe hypoglycemia. In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. In the event of an overdose of WEGOVY, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of WEGOVY of approximately 1 week.
6DESCRIPTION
WEGOVY (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C
- Figure 1. Structural Formula of Semaglutide
WEGOVY is a sterile, aqueous, clear, colorless solution. Each 0.5 mL single-dose pen contains a solution of WEGOVY containing 0.25 mg, 0.5 mg or 1 mg of semaglutide; and each 0.75 mL single-dose pen contains a solution of WEGOVY containing 1.7 or 2.4 mg of semaglutide. Each 1 mL of WEGOVY contains the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; sodium chloride, 8.25 mg; and water for injection. WEGOVY has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
WEGOVY injection is a clear, colorless solution in a prefilled, disposable, single-dose pen-injector with an integrated needle. It is supplied in cartons containing 4 pen-injectors in the following packaging configurations:
Storage and Handling
Store the WEGOVY single-dose pen in the refrigerator from 2°C to 8°C (36°F to 46°F). If needed, prior to cap removal, the pen can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days. Do not freeze. Protect WEGOVY from light. WEGOVY must be kept in the original carton until time of administration. Discard the WEGOVY pen after use.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Risk of Thyroid C-cell Tumors
Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician
Acute Pancreatitis
Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that sometimes radiates to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue WEGOVY promptly and contact their physician if pancreatitis is suspected
Acute Gallbladder Disease
Inform patients of the risk of acute gallbladder disease. Advise patients that substantial or rapid weight loss can increase the risk of gallbladder disease, but that gallbladder disease may also occur in the absence of substantial or rapid weight loss. Instruct patients to contact their healthcare provider for appropriate clinical follow-up if gallbladder disease is suspected
Hypoglycemia
Inform patients of the risk of hypoglycemia and educate patients on the signs and symptoms of hypoglycemia. Advise patients with diabetes mellitus on glycemic lowering therapy that they may have an increased risk of hypoglycemia when using WEGOVY and to report signs and/or symptoms of hypoglycemia to their healthcare provider
Acute Kidney Injury Due to Volume Depletion
Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider
Severe Gastrointestinal Adverse Reactions
Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of semaglutide, the active ingredient in WEGOVY. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking WEGOVY and seek medical advice promptly if such symptoms occur
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes
Inform patients with type 2 diabetes to contact their physician if changes in vision are experienced during treatment with WEGOVY
Heart Rate Increase
Instruct patients to inform their healthcare providers of palpitations or feelings of a racing heartbeat while at rest during WEGOVY treatment
Suicidal Behavior and Ideation
Advise patients to report emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients that if they experience suicidal thoughts or behaviors, they should stop taking WEGOVY
Pulmonary Aspiration During General Anesthesia or Deep Sedation
Inform patients that WEGOVY may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking WEGOVY
Pregnancy
WEGOVY may cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients who are exposed to WEGOVY during pregnancy to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com
Missed Doses
Inform patients if a dose is missed and the next scheduled dose is more than 2 days away (48 hours), administer WEGOVY as soon as possible. If one dose is missed and the next scheduled dose is less than 2 days away (48 hours), do not administer the dose. Inform patients to resume their regular once weekly dosing schedule
Marketed by: Novo Nordisk Inc., Plainsboro, NJ 08536
For additional information about WEGOVY contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-833-934-6891
WEGOVY
Patent Information: http://www.novonordisk-us.com/products/product-patents.html
© 2025 Novo Nordisk
9Medication Guide
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2025
10wegovy® 0.25 mg
NDC 0169-
0.25 mg
wegovy
(semaglutide) injection
0.25 mg/0.5 mL
Use Wegovy 1 time a week
4 Single-Dose Prefilled Pens
Each pen delivers a single dose of 0.25 mg semaglutide
For subcutaneous use only
Single-Dose only
Rx only
Contains: 4 Wegovy pens, Product Literature.
Dispense the enclosed Medication Guide to each patient.
11wegovy®mg
NDC 0169-
0.5 mg
wegovy
(semaglutide) injection
0.5 mg/0.5 mL
Use Wegovy 1 time a week
4 Single-Dose Prefilled Pens
Each pen delivers a single dose of 0.5 mg semaglutide
For subcutaneous use only
Single-Dose only
Rx only
Contains: 4 Wegovy pens, Product Literature.
Dispense the enclosed Medication Guide to each patient.
12wegovy®mg
NDC 0169-
1 mg
wegovy
(semaglutide) injection
1 mg/0.5 mL
Use Wegovy 1 time a week
4 Single-Dose Prefilled Pens
Each pen delivers a single dose of 1 mg semaglutide
For subcutaneous use only
Single-Dose only
Rx only
Contains: 4 Wegovy pens, Product Literature.
Dispense the enclosed Medication Guide to each patient.
13wegovy®mg
NDC 0169-
1.7 mg
wegovy
(semaglutide) injection
1.7 mg/0.75 mL
Use Wegovy 1 time a week
4 Single-Dose Prefilled Pens
Each pen delivers a single dose of 1.7 mg semaglutide
For subcutaneous use only
Single-Dose only
Rx only
Contains: 4 Wegovy pens, Product Literature.
Dispense the enclosed Medication Guide to each patient.
14wegovy®mg
NDC 0169-
2.4 mg
wegovy
(semaglutide) injection
2.4 mg/0.75 mL
Use Wegovy 1 time a week
4 Single-Dose Prefilled Pens
Each pen delivers a single dose of 2.4 mg semaglutide
For subcutaneous use only
Single-Dose only
Rx only
Contains: 4 Wegovy pens, Product Literature.
Dispense the enclosed Medication Guide to each patient.
